Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Parathyroid hormone (pg/mL)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women aged ≥40 years
- •Menopausal women, period of early menopause 1-10 years
排除标准
- •Inclusion in other study protocols
- •estrogen-replacement hormone therapy
- •osteoporosis therapy
- •corticosteroid therapy
- •insulin therapy.
- •calcium supplementation
- •kidney diseases of medium-severe level
- •liver diseases of medium-severe level
- •severe osteoporosis
结局指标
主要结局
Parathyroid hormone (pg/mL)
时间窗: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
calcium (mg/dL)
时间窗: 0-3-6 month
change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests
25-OH vitamin D (ng/mL)
时间窗: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
osteocalcin (ng/mL)
时间窗: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
次要结局
- NMR metabolomic profile and applications of Metabolomics in calcium metabolism(0-3-6 month)
研究者
Luca Rastrelli
Principal Investigator Full Professor Luca Rastrelli
University of Salerno